A Two Minute Test for the AIDS Virus Given First U.S. Field Trial in the Bronx
Sawuya Lubega
1276 Fulton Ave
3rd Floor Department of Family Practice
Bronx, NY 10456 718/901-8749
Paper C-138, Session 108C
A test for HIV, the virus that causes AIDS, that is as simple to give as a pregnancy test, is very reliable, takes just a few minutes to show results without the use of sophisticated laboratory equipment, and costs less than one tenth as much as currently used screening tests, has recently been given its first field trial in the United States by a group of researchers at the Bronx-Lebanon hospital Center, in the Bronx, New York. The trial was carried out in two phases. In the first, specimens previously identified as positive or negative for AIDS virus were tested with the MedMira Rapid HIV Screen and the results compared. In the second, specimens received at the hospital laboratory in a "real time situation" were tested with both standard tests and the MedMira test. The overall accuracy of the MedMira Rapid HIV Screen for the clinical trial was 99.6%, whereas that for the Standard Screen test was 99.8%. In the laboratory assessment, the MedMira test detected all of the 283 positive samples and 845 of the 850 negative samples. The MedMira test was then evaluated in comparison with the Standard Screen test in a routin clinical setting, and of the 15,85 consecutive patients assessed, 129 (8.1%) were confirmed HIV+. The MedMira test detected all put 3 positive cases; one of which was in early stages of HIV infection. In the remaining 1,456 negatives, both the Standard Screen and the MedMira test showed i! dentical results with 3 false positive reactions. The MedMira Rapid HIV Screen, developed by MedMira Laboratories, Ltd. of Canada, has many benefits. The most important is that close to 40% of people who visit a doctor's office or a clinic for an AIDS test never return for results. The MedMira test offers results in just a few minutes -- preventing those who have AIDS from becoming unwitting transmitters. Additionally the MedMira Rapid HIV Screen shortens the anxiety felt by patients who currently wait for up to several days for results of the standard Western Blot test to come back from a laboratory. Those whose MedMira test results are negative would be informed of their negative status immediately. Those who test positive would be told that results are uncertain, and given a confirmation Western Blot test, which requires several days for results. Professional counseling would be immediately available, in any case. Because of the need for the confirmation test and appropriate counseling, the MedMira test will not be markete! d for home use. "HIV testing is the cornerstone of world-wide HIV prevention and treatment, in developing countries, where it is estimated that over 90% of all infected people live," says Dr. Sawuya N. Lubega, initiator of the field testing project and currently a second-year resident at the Bronx-Lebanon Residency in Urban Family Medicine. "Access to HIV testing is severely limited in developing countries due to scarcity of funds and the sophisticated equipment necessary to perform the standard tests. The World Health Organization has recommended development of alternate testing strategies." Dr. Lubega began her work in AIDS research in her home country, Uganda, where AIDS is a growing problem. She hopes to continue doing research when she returns to Uganda after finishing her medical residency. "I'm pursuing my dream to be part of the solution to the problem of AIDS." Rapid HIV testing could prove highly useful in a variety of settings both abroad and in the U.S: examinations of pregnant women, organ donor screening, situations requiring emergency care, accidental exposure on the job, as well as in drug treatment programs and clinics that treat sexually transmitted diseases. Bronx-Lebanon Hospital Center serves an area of the Central and South Bronx that has one of the highest HIV prevalence rates in the United States. In 1996, while a first-year resident, Dr. Lubega proposed field testing of the MedMira Rapid HIV Screen to three groups: her associates at the Bronx Residency in Urban Family Medicine; the research group of the Institute for Urban Family Health, which runs the residency program collaboratively with Bronx-Lebanon Hospital Center; and the hospital's Department of Pathology. Testing began in early 1997 and continues through 1998. Richard R. Hwang, M.D., a resident in pathology, was Dr. Lubega's principal associate in the testing process. Other co-investigators included Mary Lutz, Ph.D., Direcotr of Research, The Institute for Urban Family Health; Paul Lyons, M.D., Associate Director, Bronx Residency in Urban Family Medicine; Bruce Soloway, M.D., Associate Director, Bronx-Lebanon Department of Family Practice; Yuan Hu, M.D., Laboratory ! Technical Assistant; and Young J. Choi, M.D., Director of Pathology, Bronx-Lebanon Hospital Center. The test itself is extremely easy to administer. The test kit, which is stable at room temperature for up to one year, contains an immunoreactive membrane enclosed within a 1" cartridge. A single drop of human serum, plasma, or whole blood is added, followed by drops of a color developing chemical. The appearance of a distinctive red dot in the center of the membrane indicates a positive reaction to HIV. Although the MedMira Rapid HIV Screen has been extensively testing in more than 15 countries in Europe, Africa, SE Asia, the Carribean and Canada, it still must undergo an FDA Evaluation at another hospital center before its use for the general population in the United States can be approved. Field testing such as that done by Dr. Lubega and her associates will help to advance the acceptance in the U.S. of this new weapon in the battle against AIDS. Funding for the field test was provided by MedMira Laboratories, Ltd. of Canada. The Bronx Residency in Urban Family Practice is a collaborative program of the Bronx-Lebanon Hospital Center and the Institute for Urban Family Health. The Institute is a non-profit organization dedicated to the development of innovative ways to provide primary health services to underserved urbn populations using the family practice model of care; sponsor innovative education and training programs for health professionals; engage in primary care health services research; and participate in national, state and local health policy development.
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